Phase 3
N=626
The Efficacy of a Toothpaste to Reduce Sensitivity
Dentin Hypersensitivity
Bottom Line
View on ClinicalTrials.gov: NCT00763269 ↗Enrolled (actual)
626
Serious AEs
0.0%
Results posted
Sep 2010
Primary outcome: Primary: Hypersensitivity Tactile(Yeaple Probe) — 19.81; 13.94 units on a scale — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Triclosan, Silicon dioxide, fluoride (Drug); Triclosan, fluoride (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Colgate Palmolive
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hypersensitivity Tactile(Yeaple Probe) |
19.81; 13.94 | 0.05 |
| PRIMARY Hypersensitivity Tactile (Yeaple Probe) |
31.90; 17.28 | 0.05 |
| SECONDARY Air Blast Hypersensitivity (4 Week) |
1.61; 2.18 | 0.05 |
| SECONDARY Air Blast Hypersensitivity (8 Week) |
0.89; 1.80 | 0.05 |
Summary
Hypersensitivity
Eligibility Criteria
Inclusion Criteria
- Male and female subjects, ages: 12 years or older.
- Availability for the eight-week duration of the study.
- Two sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession.
- Qualifying response to Tactile stimuli (Yeaple Probe) as defined by a score between 10-50 grams of force.
- Qualifying response to the Air Blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
- Subjects need to satisfy the qualifying response to stimuli for both parameters assessed (Tactile or Air Blast) on at least two teeth to be entered into the study.
- Good general health with no known allergies to products being tested.
- Use of a non-desensitizing dentifrice for one month prior to entry into the study.
- Signed Informed Consent Form.
Exclusion Criteria
- Gross oral pathology, chronic disease, or history of allergy to test products.
- Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
- Sensitive teeth with a mobility greater than one.
- Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
- Regular use of anticonvulsants, antihistamines, sedatives, tranquilizers, anti-inflammatory drugs, or analgesics.
- Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past one month.
- Current participation in any other clinical study.
- Allergies to triclosan, or oral care products, personal care consumer products, or their ingredients.
- Medical condition which prohibits not eating/drinking for 4 hours.
Data sourced from ClinicalTrials.gov (NCT00763269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.